Hive Standalone Alif System
38W x 26L x 17H, 15° - Peel Pouch Packaging Configuration
3manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | NanoHive Medical LLC, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K200541 |
| Record published | 2023-08-31 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Width 32 to 38 mm; length 26 mm; height 11 to 19 mm; angle 8 to 22 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 06-A-0006-4017 | Width 38 mm | In distribution |
| 06-A-0007-4013 | Width 38 mm | In distribution |
| 06-A-0004-4013 | Width 32 mm | In distribution |
| 06-A-0007-4017 | Width 38 mm | In distribution |
| 06-A-0007-4019 | Width 38 mm | In distribution |
| 06-A-0002-4011 | Length 26 mm | In distribution |
| 06-A-0002-4013 | Width 32 mm | In distribution |
| 06-A-0006-4013 | Width 38 mm | In distribution |
| 06-A-0005-4013 | Width 38 mm | In distribution |
| 06-A-0008-4015 | Width 32 mm | In distribution |
| 06-A-0002-4015 | Width 32 mm | In distribution |
| 06-A-0004-4015 | Width 32 mm | In distribution |
| 06-A-0007-4015 | Width 38 mm | In distribution |
| 06-A-0005-4017 | Width 38 mm | In distribution |
| 06-A-0004-4017 | Width 32 mm | In distribution |
| 06-A-0002-4017 | Width 32 mm | In distribution |
| 06-A-0006-4019 | Width 38 mm | In distribution |
| 06-A-0006-4015 | Width 38 mm | In distribution |
| 06-A-0005-4015 | Width 38 mm | In distribution |
| 06-A-0004-4011 | Width 32 mm | In distribution |
| 06-A-0008-4013 | Width 32 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.